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System Specifications

Assay technology

Chemiluminescent immunoassay

Sample Types

Serum, Plasma

Assay channels

4 or 6 (Channels are configured for specific assays during installation by an Abbott representative.)

Sample racks

28 positions per rack Maximum 10 racks*

Reaction trays

16 reaction cells per tray Maximum loading: 27 trays per tray loader*

Sample dispense volume

50-100 μL ± 10%

System control center

VGA-compatible color monitor with keyboard

Dimensions(HxWxD)

68” x 91.6” x 33.1” 1.73 x 2.33 x .84 m

Weight

1660 lb 753 kg

Uninterruptiblepower supply

Single phase 200-240 VAC ± 10%

Footnote:*Continuous access

ABBOTT PRISMnEXT SYSTEM INTENDED USE AND IMPORTANT SAFETY INFORMATION

Intended Use

The ABBOTT PRISMnEXT is an automated immunoassay analyzer designed to perform Chemiluminescent Immunoassay (ChLIA) technology. The ABBOTT PRISMnEXT performs batch/continuous access and STAT processing of specimens containing both large and small molecular weight analytes.

Usage and Safety Information

System operators must be aware of both biohazardous risks and risks inherent in operating electromechanical equipment and are responsible for using the system only as designed. Failure to follow safe use instructions could cause injury to the operator, damage to the system, or adversely affect assay results.

INTENDED USE AND IMPORTANT SAFETY INFORMATION

For In Vitro Diagnostic Use Only

Caution: United States Federal Law restricts these devices to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. These products contain human-sourced and/or potentially infectious components and must be handled in accordance with the OSHA Standard on Bloodborne Pathogens.

For complete assay information, see the assay specific package insert.

ABBOTT PRISM CHAGAS

Intended Use: The ABBOTT PRISM Chagas assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to Trypanosoma cruzi (T cruzi), the causative agent of Chagas disease, in human serum and plasma specimens. The ABBOTT PRISM Chagas assay is intended to screen individual human donors, including volunteer donors of whole blood and blood components and other living donors, for the presence of antibodies to T cruzi. The assay is also intended for use in testing serum and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non–heart-beating) donors. It is not intended for use on cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of T cruzi infection.

ABBOTT PRISM HIV O PLUS

Intended Use: The ABBOTT PRISM HIV O Plus assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to HIV-1 (anti-HIV-1) Groups M and O and/or antibodies to HIV-2 (anti-HIV-2) in human serum and plasma specimens. The ABBOTT PRISM HIV O Plus assay is intended to screen individual human donors, including volunteer donors of Whole Blood and blood components and other living donors, for the presence of anti-HIV-1 Groups M and O and/or anti-HIV-2. The assay is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, in testing blood specimens to screen cadaveric (non–heart-beating) donors, and as an aid in the diagnosis of HIV-1/HIV-2 infection. It is not intended for use in testing cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ABBOTT PRISM HEPATITIS B VIRUS CORE ANTIGEN

Intended Use: The ABBOTT PRISM HBcore assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma specimens. The product is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors to prevent transmission of hepatitis B virus (HBV) from such donors. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe wa.

ABBOTT PRISM HEPATITIS B SURFACE ANTIGEN

Intended Use: The ABBOTT PRISM HBsAg assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma specimens. The ABBOTT PRISM HBsAg (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ABBOTT PRISM HBSAG CONFIRMATORY

Intended Use: The ABBOTT PRISM HBsAg Confirmatory assay is an in vitro qualitative chemiluminescent immunoassay (ChLIA) used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization. The ABBOTT PRISM HBsAg Confirmatory assay is intended to be used for confirmation of samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HBV infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ABBOTT PRISM HCV

Intended Use: The ABBOTT PRISM HCV assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to hepatitis C virus (anti‑HCV) in human serum and plasma specimens. The ABBOTT PRISM HCV (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HCV. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens to screen cadaveric (non-heart beating) donors. It is not intended for use on cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HCV infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

ABBOTT PRISM HTLV‑I/HTLV‑II

Intended Use: The ABBOTT PRISM HTLV‑I/HTLV‑II assay is an in vitro chemiluminescent immunoassay (ChLIA) for the qualitative detection of antibodies to human T‑lymphotropic virus Type I and/or human T‑lymphotropic virus Type II (anti‑HTLV‑I/HTLV‑II) in human serum and plasma specimens. The ABBOTT PRISM HTLV-I/HTLV-II (ChLIA) is intended to screen individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.

Important Safety Information: Package insert instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in the package insert. The performance characteristics of this product have not been established for the laboratory diagnosis of HTLV-I/HTLV-II infection. This product contains sodium azide. Contact with acids liberates very toxic gas. This material and its container must be disposed of in a safe way.

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